1. Field of the Invention
The present disclosure relates generally to medical devices and procedures. In particular, the present disclosure relates to expandable medical devices, such as introducer sheaths, for use during medical procedures.
2. Description of the Prior Art
This section provides background information related to the present disclosure which is not necessarily prior art.
Numerous procedures have been developed that involve the percutaneous insertion of a medical device into the body of a patient, with the medical device being introduced into the body by a variety of known techniques. For example, access to coronary arteries, carotid arteries, the aorta, and peripheral vessels or other tubular members of the body for percutaneous therapeutic, diagnostic, and guide catheters is often made through introducer sheaths which are positioned into body vessels from outside the bodies. Such access sites include, but are not limited to, the common femoral artery/vein and the radial arteries, as well as the ureter, urethra, intestinal track, veins and other tubular tissues. However, the use of introducer sheaths and/or medical devices which are large relative to the body vessels to which they are inserted poses risks and challenges to both the patient and the physician.
For example, relative to femoral sheaths and catheters, larger introducer sheaths create sizeable arteriotomies in the femoral artery which cause more trauma to the patient, such as through artery avulsion, and create more challenges in placement of the sheath with risk of dissection. In addition, the forces required by the physician to insert the larger introducer sheaths and/or medical devices into the body vessel can be higher than desired and create medical issues for the patient if calcification within the body vessel is dislodged during insertion of the introducer sheath and/or medical device.
Methods of accessing a body vessel with a larger introducer sheath and/or medical device can begin by dilating the vessel with a radially expanding intravascular sheath assembly prior to introducing the medical device. However, such radially expanding sheaths have complex mechanisms, such as ratcheting or balloon mechanisms, that expand and maintain the sheath in an expanded configuration while a medical device with a large diameter is introduced. Further, since the mechanisms effectuate the expansion of the body vessel, they do not provide a user with tactile feedback, and can even pose a risk of dissection during the procedure. Accessing the body vessel remains a challenge with existing expandable sheath assemblies due to the relatively large profile of the medical device inserted which causes longitudinal and radial tearing of the vessel during insertion. As mentioned above, these prior art delivery systems can even dislodge calcified plaque within the vessels during insertion, posing an additional risk of clots caused by the dislodged plague.
Accordingly, there remains a need in the art for an improved expandable introducer sheath for use with the percutaneous insertion of a medical device into a body vessel of a patient.